Effects of amino acids on nonalcoholic fatty liver disease

Effect of oral amino acid preparations on insulin resistance in nonalcoholic fatty liver disease: multicenter, randomized, double-blind comparative study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031210207

Enrollment

Registered

2021-07-27

Start date

2021-07-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic fatty liver disease NAFLD, NASH

Interventions

Treatment Group: Glycine (3000 mg) given on 3 times daily for 2 weeks Control Group: Casein (3000 mg) given on 3 times daily for 2 weeks

Amino Acid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 to 80 y.o 2) Outpatients diagnosed with fatty liver by abdominal ultrasonography (positive hepato-renal contrast or CAP value of 220 dB/m or more on FibroScan) during the pre-observation period (0 to 16 weeks) and have a HOMA-IR of 2.5 or higher 3) Patients who have written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients with ethanol consumption > 20 g/day for women and > 30 g/d for men 2. Patients who are being treated for chronic liver disease other than steatohepatitis 3. Liver cirrhosis and/or high-risk case of hepatic encephalopathy 4. Patients treated with insulin 5. Patients with severe ketosis, diabetic coma or precoma, of type 1 diabetes 6. Women that might be pregnant or pregnancy 7. Patients with schizophrenia 8. Patients allergic to milk and/or dairy products 9. Patients judged to be ineligible by the investigator

Design outcomes

Primary

Measure	Time frame
Change in HOMA-IR value (fasting insulin level (uU /ml) x fasting blood glucose level (mg /dl) /405) 2 weeks after administration from baseline	—

Secondary

Measure	Time frame
Blood glucose level and serum insulin, glucagon and C-peptide immunoreativity levels during 75g OGTT, Change of serum AST, ALT, ALP, gGTP, the markers for inflammation (high sensitive CRP, TNFa), total cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerol (TG), non-esterified fatty acid, CAP, liver stiffness, body weight, BMI, muscle mass, water volume, visceral fat amount, skeletal muscle mass index (SMI) and adverse effects.	—

Measure

Time frame

Blood glucose level and serum insulin, glucagon and C-peptide immunoreativity levels during 75g OGTT, Change of serum AST, ALT, ALP, gGTP, the markers for inflammation (high sensitive CRP, TNFa), total cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerol (TG), non-esterified fatty acid, CAP, liver stiffness, body weight, BMI, muscle mass, water volume, visceral fat amount, skeletal muscle mass index (SMI) and adverse effects.

—

Contacts

Public ContactKazuyoshi Kon

Juntendo University Hospital

kazukon@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026